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Lord Warner: My Lords, I hope that I can give some reassurance that what is sought by the amendment is already allowed for in the Bill. Clause 1(7) to (9) allows tissue taken from the living to be stored or used for research purposes without consent where two safeguards are met. Those are, first, that the research has ethical approval, and secondly, that the research is or is going to be carried out in circumstances such that the researcher does not know and is not likely to find out the identity of the person whose tissue it is.

We have used the shorthand of "anonymisation" when referring to the second of those two safeguards. In practice, it means separating from the tissue any information which links it to an identifiable individual. Non-identifying information, which may be very important for the purposes of the research, may still be kept with the tissue, and it would be possible to seek further non-identifying information relating to a particular sample if necessary during the research, provided that the person's identity remained confidential. As we have said on several occasions, the Bill does not require such tissue to be permanently unlinked from the patient record.

Therefore, it will not be an offence to store or use tissue for research purposes without consent where a researcher doing REC-approved research does not know the person's identity. How the removal of patient identifiers from the tissue is achieved is not regulated by the Bill. A clinician who wants to carry out research using material from his own patients could, prior to commencing the research project, anonymise all or some of the patient's material. Once that was done and REC approval was obtained, he could commence the research.
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The clinician would need to be sure, however, that he met the requirement in Clause 1(9)(b) that he was not likely to come into possession of the patient's identity. He would need either to unlink the tissue and identifying information, or to make arrangements for secure holding of the "key" which links the tissue to particular patients. That would apply whether the laboratory or organisation was small, medium or large.

Although the Bill does not prevent a clinician anonymising his own patient records prior to commencing use of them in research, the clinician would need to be satisfied that he would not need to and would not be likely to come into possession of identifying information. As such, he may consider it simpler to involve a third party for the purpose of anonymisation. However, that is not actually required by the Bill. In any event, I can reassure noble Lords that Clause 1(9)(b)—I invite them to undertake a careful reading of it—does not prevent anonymisation activities where they are done prior to commencement of research.

Earl Howe: My Lords, I am grateful to the Minister. I well appreciate that his reply is intended to be helpful, and I am sure that it takes us further forward. However, I confess to being quite puzzled by it. In a small laboratory setting with perhaps a few named samples on the table, it would seem a bit difficult for any researcher, even if he or she carried out the process of anonymisation, not to have some memory recall of the identity of the person to whom each sample related. In those circumstances, the researcher would infringe subsection (9)(b), as he or she could not stand up and say that they were unlikely to come into possession of the knowledge of who the people were.

There may still be an issue here in certain laboratory settings. It has been put to me that it is certainly not enough simply to remove the name of a patient from the tissue sample and believe that one has thereby anonymised it. Quite often one finds that the hospital number remains as an identifier. Certainly in the eyes of many doctors and the GMC, that is not sufficient to preclude the possibility of the person's identity becoming known at some stage in future.

I shall withdraw the amendment; it was in essence a probe. However, the best thing for me to do is to consider the Minister's reply and see whether the matter could not be further clarified at the Bill's final stage. In the mean time, I am grateful to the Minister for putting his reassurance on record. I beg leave to withdraw the amendment.

Amendment, by leave, withdrawn.

Earl Howe moved Amendment No. 3:

The noble Earl said: My Lords, I tabled a series of amendments for Grand Committee designed to ensure that, before exercising a number of the delegated powers in the Bill, the Secretary of State should consult
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such persons as he considered appropriate. I obviously had in mind members of the medical and scientific communities. I have not retabled all those amendments. Instead, I have come back to Clause 1(11), because it has particular importance in the context of the Bill as a whole.

We should remind ourselves that the Bill has emerged from a series of very regrettable medical scandals. I am sure that we have before us a carefully drafted set of provisions. We may not all agree on some of their details, but we are all signed up to the main principles on which the Bill rests, as my noble friend Lord Jenkin pointed out earlier. The Government have steadfastly resisted change to the main planks of the Bill. I understand why they have done that, although I do not always agree that they should be so absolutist in their approach.

Despite the Government's firm stance, we find in subsection (11) a delegated power of a potentially far reaching nature. It is so far reaching that it drew comment from the Select Committee on Delegated Powers and Regulatory Reform. The committee commented that, although the delegation contained in the subsection was not in its opinion inappropriate,

The Minister did not specifically respond in Grand Committee to those comments. Having thought about this for quite some time, I have some doubts, as the Committee indicated as well, about whether the criteria for the exercise of this power can be formulated in a satisfactory way.

My amendment requiring the Secretary of State to consult comes at the issue from the other direction. It effectively says that the criteria for the exercise of the power should be examined by those whom the power most affects—namely, the medical and scientific communities—at such time as the Secretary of State may wish to change Schedule 1. Let us remind ourselves that Schedule 1 is very much the linchpin upon which the Bill rests. As we are all aware, it contains a list of those activities in Part 1 where consent is normally required and in Part 2 where it is normally not required. Those lists have been drawn up after extensive thought and consultation.

In Grand Committee, the Minister said it would be unthinkable for any Secretary of State to come to either House of Parliament and present an affirmative instrument without having consulted those whom it directly affected. I can see that; it would be a brave Minister who would do that. But to me, that is not the issue. We need to send out the same kind of reassuring messages with this clause as we do with some of the rest of the Bill. The public need to know that proper consultation will take place; the scientific and medical communities need to know that proper consultation will take place. I do not think that placing a requirement of this kind in the Bill is, if I can put it colloquially, any skin off the Government's nose. I would feel very reassured if the Minister felt able to
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agree to the proposal contained in the amendment. I hope that he will look at it constructively. I beg to move.

Baroness Neuberger: My Lords, I support the noble Earl, Lord Howe, in the amendment. I feel, as he does, that the public would be much reassured by seeing on the face of the Bill that the scientific and medical communities as well as patient groups and the voluntary sector had been suitably consulted.

Baroness O'Neill of Bengarve: My Lords, I think there is a great point to this addition. We have to remember that Schedule 1, which, as the noble Earl has said, is the linchpin of the Bill, contains in each of its halves a list of activities to be treated differently—those normally requiring consent and those not normally requiring consent—but that the lists are not exhaustive. There are many gaps, and many things that fall under none of the headings in Schedule 1. It is, as we saw from the debate on Amendment No. 1, not clear that these matters are mutually exclusive. In those circumstances, I think it highly likely that the Minister or his successors will be back with suggestions about variations in Schedule 1.

Lord Warner: My Lords, let me reassure the noble Earl, Lord Howe, that I do not have the bravery to come before the House with amendments of this kind without having gone through an extensive process of consultation.

A similar amendment was proposed in Grand Committee. I sought to reassure noble Lords at that time that the Secretary of State would consult appropriately before exercising his powers to change the scope of the regulated activities. As I said then, it is customary for consultation with relevant stakeholders to take place before substantive changes are made to legislation. We certainly do not plan to do things differently in relation to the Bill.

However, I recognise that there are concerns in your Lordships' House and outside. Having listened to your Lordships' obvious concerns about this matter, I am content to take the point away to reconsider it with colleagues and to come back to it at Third Reading.

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